- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123261
Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being
Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being of Institutional Seniors With Disability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Existing literature indicates that seniors with disabilities living in long-term care institutions are confronted with such issues as changes in their living environment, institutionalized living schedules, and reduced social interaction, which may affect their mental health and cause spiritual disturbances. In recent years, mindfulness therapy has been increasingly proven to effectively improve individuals' mental health and spiritual well-being. However, the effectiveness of the therapy for seniors with disabilities admitted to residential institutions needs to be further verified by empirical studies.
Purpose: This study aims to verify the effectiveness of the mindfulness-based elder care (MBEC) therapy developed by McBee (2008) in improving the psychological and spiritual well-being of seniors with disabilities living in residential long-term care institutions in Taiwan.
Methods: A Randomized control trial was used. The subjects enrolled in this study were the seniors with disability in the residential long-term care institutions in the northern and central part of Taiwan. The inclusion criteria were the seniors with disabilities who (1) lived in a care institution for over 3 months; (2) were aged 65 years or above; (3) failed to obtain a full score for Barthel Index; (4) were able to communicate in Mandarin or Taiwanese; and (5) had no history of mental illness. According to the intervention scheme, the experimental group was offered eight 50-minute courses once a week, while the control group maintained routine activities. In terms of the evaluation of intervention effectiveness, basic data collection tables, and the Barthel Index were used to collect the information of the included seniors with disabilities on basic demography, and ability to perform daily activities. The Geriatric Depression Scale-Short-Short Form (GDS-SF), State Trait Anxiety Inventory (STAI), and Spiritual Well-Being Scale (SWBS) were also adopted to understand the included seniors with disabilities depression, anxiety, and spiritual well-being. The data were collected four times: before the intervention, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week). The collected data was analyzed by SPSS 22.0. Descriptive statistics and the independent samples t-test were used to identify the homogeneity of the two groups, and the linear mixed model was used to compare the improvement results of the experimental group alone and the two groups at different time points.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan
- Department of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- The inclusion criteria were the seniors with disabilities who (1) lived in a care institution for over 3 months; (2) were aged 65 years or above; (3) failed to obtain a full score for Barthel Index; (4) were able to communicate in Mandarin or Taiwanese; and (5) had no history of mental illness.
- The exclusive criteria were residents have the diagnosis of psychotic disorders, infectious diseases, or been hospitalized.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the mindfulness-based elder care (MBEC) therapy
The experimental group was offered eight 50-minute courses once a week.
|
According to the mindfulness-based elder care (MBEC) therapy developed by McBee (2008), the experimental group was offered eight 50-minute courses once a week.
|
|
No Intervention: the routine activities
The control group maintained routine activities.
And each CG participant had a weekly visit from the research team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression summary scores before intervention to 4-week post intervention.
Time Frame: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
Depression was measured using the Chinese version of the Geriatric Depression Scale-Short-Short Form (GDS-SF).
The Geriatric Depression Scale-Short-Short Form scores range from 0 to 15.
Higher scores represent an increased level of depressive symptoms and a cut-off value of 5 is commonly indicative of depression.
|
The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
|
Change in Anxiety summary scores before intervention to 4-week post intervention.
Time Frame: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
Anxiety was measured using the Chinese version of the State Trait Anxiety Inventory (STAI).
The State Trait Anxiety Inventory measures two types of anxiety - state anxiety, or anxiety about an event.
The total scores range from 40-160 and higher scores are positively correlated with higher levels of anxiety.
|
The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
|
Change in Spiritual well-being summary scores before intervention to 4-week post intervention.
Time Frame: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
Spiritual well-being was measured using the Chinese version of the Spiritual Well-Being Scale (SWBS).
The Spiritual Well-Being Scale scores range from 20 to 120.
Higher scores represent an increased level of spiritual well-being.
|
The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Meaning in life summary scores before intervention to 4-week post intervention.
Time Frame: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
Meaning in life was measured using the Purpose in Life Test (PIL).
The Purpose in Life Test scores range from 20-140 and higher scores are represent an higher level of meaning and purpose in respondents' lives.
|
The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yi-Heng Chen, PhD, Department of Nursing, Mackay Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MOST-103-2314-B-715-002-MY3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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